A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer

Last updated: February 23, 2023
Sponsor: Celgene
Overall Status: Terminated

Phase

1

Condition

Carcinoma

Lung Cancer

Treatment

N/A

Clinical Study ID

NCT03906526
VTX-2337-HN-001
U1111-1223-3488
  • Ages > 18
  • All Genders

Study Summary

This is an open label, Phase 1b pre-operative window of opportunity biomarker trial to analyze the combination of intravenous (IV) anti-PD-1 inhibitor, nivolumab, given along with toll-like receptor 8 (TLR 8) agonist motolimod delivered either subcutaneously (SC) or by intratumoral injection (IT) in subjects with squamous cell carcinoma of the head and neck (SCCHN). Subjects with previously untreated, resectable SCCHN, will be recruited onto this trial and will initially undergo pre-treatment diagnostic imaging and biological sample collection. These subjects will undergo pre-operative study treatment for a 3 to 4-week period prior to a scheduled surgical resection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Subject has Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
  • Subject has a new clinical or pathologic diagnosis of resectable HPV+ or HPV- SCCHN ofthe oral cavity, pharynx, or larynx
  • Macroscopic complete resection of the primary tumor must be planned and subjectsshould have no medical contraindication to surgery.
  • Subject consents to and has tumor accessible for tumor biopsy pre-treatment.
  • Subjects must have acceptable hematopoietic, liver, renal, and coagulation function asassessed by laboratory tests.

Exclusion

Exclusion Criteria:

  • Subject has any significant medical condition, laboratory abnormality, or psychiatricillness that would prevent the subject from participating in the study
  • Subject has unresectable or inoperable tumors
  • Subject has primary tumors of the sinuses, paranasal sinuses, or nasopharynx, orunknown primary tumors
  • Subject has evidence of distant metastasis
  • Subject is a pregnant or nursing female.
  • Subject has active or uncontrolled infection including known HIV infection or knownchronic hepatitis B or C.
  • Subject has active autoimmune disease.
  • Subject has clinically significant ophthalmologic disease.

Study Design

Total Participants: 15
Study Start date:
July 03, 2019
Estimated Completion Date:
January 24, 2022

Connect with a study center

  • Local Institution - 112

    Birmingham, Alabama 35294-3300
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294-3300
    United States

    Site Not Available

  • University of California San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kansas

    Lawrence, Kansas 66045
    United States

    Site Not Available

  • University of Kansas

    Westwood, Kansas 66205-2003
    United States

    Site Not Available

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Boston University

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 116

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution - 102

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267-0501
    United States

    Site Not Available

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Local Institution - 101

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • University of Pittsburgh Medical Center Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Local Institution - 103

    Sioux Falls, South Dakota 57104-8805
    United States

    Site Not Available

  • Sanford Cancer Center

    Sioux Falls, South Dakota 57104-8805
    United States

    Site Not Available

  • The University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

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